LINX Reflux Management System
FDA premarket approval P100049/S029 · decided 2022-08-26
Approval details
- PMA number
- P100049
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LINX Reflux Management System
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2021-01-12
- Decision date
- 2022-08-26
- Days to decision
- 591 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Approval for the qualification of a new supplier to manufacture the washer, bead case-female, bead case-male and clasp case.
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